While Paradigm Spine's coflex has been available for several years, in 2018 several major payers announced favorable coverage decisions, including most recently Priority Health of Michigan, BlueCross BlueShield of North Dakota and BlueCross BlueShield of South Carolina. This is additive to the previously approved payers, BCBS Michigan, BCBS Highmark, and Health Alliance.
The North American Spine Society also released a positive coverage policy recommendation for lumbar interlaminar devices without fusion but with decompression in May. At the NASS 2018 Annual Meeting in Los Angeles, Chairman and CEO of Paradigm Spine Marc Viscogliosi discussed how those coverage decisions are helping propel coflex in the future.
Question: There have been several new favorable coverage decisions for coflex over the past several months. What does that mean for Paradigm Spine?
Marc Viscogliosi: Payer coverage is something we've been focused on for a number of years now. It's taken quite a lot of energy to develop the evidence that the payers desire to see. We work very hard with clinicians all over the world to develop prospective randomized clinical trials with long term data as well as level 2 and level 3 studies to support the clinical outcomes that coflex generates and the evidence payers require.
As payers have started to adopt coflex coverage policies, we've seen a strong desire by surgeons to offer coflex to their patients. There is a strong need and demand by patients to obtain access to coflex and payer coverage now allows that. What we've seen is that we've been very tight to our training initiatives so that surgeons offer coflex on label per the indications and really achieve the desirable consistent and reproducible results that they come to expect with coflex. In doing that, what really happens is a groundswell builds in the market and we've been excited to continue to reinforce the value proposition that coflex offers.
We are excited for the payer coverage dynamic to continue to happen both regionally and nationally.
Q: How will Paradigm Spine grow over the next few years?
MV: Where we are very focused now is on procedural evolution and enhancement of the coflex procedure. The implant itself is genius in its simplicity, and we want to really enhance the procedural solutions around that.
These enhanced procedural solutions are really designed to be comprehensive in terms of integrating all the attributes of the decompression procedure in an efficient, effective [and] reproducible manner to allow the implant to be delivered minimally invasively through a tube or laterally for surgeons that prefer to retain the supraspinous ligament at post decompression. These enhancements really are designed to extend the benefits of the coflex outcomes to surgeons that really want to integrate their procedural differentiations and training and attributes to the implant and marry the procedural and implant innovation together.
We are working pretty aggressively on the [research and development] aspects of that and we're working very closely with the FDA to bring those procedural enhancements to the market.
A final takeaway is that coflex is a PMA FDA-approved device, giving it a regulatory competitive advantage.
Q: What is the value proposition of the coflex procedure?
MV: It allows the surgeons to decompress and open up the space around the nerves whether its bone or soft tissue to really relieve pain, but it is also a motion preservation and stabilization device; this stabilization occurs without any of the drawbacks of fusion, which is a morbid procedure – an aggressive procedure – and results in a long and difficult patient recovery. Especially in older patients, what's really important is that they have an active quality of life. They want to get back with their daily activities and spending time with their families or athletics, and coflex really allows that to happen. We're seeing that as a really important part of the value proposition.
Q: In the spine field there is the trend toward the less invasive procedures and less morbid. Could you speak to the outpatient trend setting?
MV: Obviously, outpatient surgery is a macro-trend. I would estimate, although it's hard to have specific numbers on this, from what we've seen approximately half of the coflex patients are treated in the outpatient setting, whether it's hospital outpatient or ASC. That's great for the patients or the payer community because it's much more cost-effective care. The surgeons really like the efficiency and straight forward approach of outpatient surgery, and if the patients really have a measurable benefit from that it's really a powerful motivator to continue to do more of it.
Q: What is the next step or the thing they should be looking out for?
MV: Our mission has always been to be surgeon centric, indication specific and data driven. We look to create technologies and product platforms that are really fulfilling a significant unmet need in a way that other products currently don't or can't do. We have a number of those products in our portfolio and we actively commercialize them internationally. Over time we expect to bring those products to market in the U.S. working closely and collaboratively with the FDA. Many of our products internationally have been on the market for a decade or so, so we have tens of thousands of patients with experience. We know how well our products function and we can develop level 1 and level 2 evidence for those devices internationally.
When we look at the comprehensiveness of our product portfolio, it's really about being able to impact all the stakeholders of care and provide better outcomes at a cheaper cost.